Recall Z-2442-2019 ยท EZY Device, Incontinence, Mechanical/Hydraulic
Boston Scientific Corporation
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. |
| Root cause | Error in labeling |
| Action | Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific |
| Quantity | 1 unit |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.